Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000086763
Ethics application status
Approved
Date submitted
17/12/2021
Date registered
24/01/2022
Date last updated
29/11/2022
Date data sharing statement initially provided
24/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The ORIENT study: Testing the effect of a nurse-led model of care in general practice on uptake of long-acting reversible contraception and access to medical abortion for women in rural and regional Australia
Scientific title
The ORIENT study: Testing the effect of a nurse-led model of care, task sharing, and telehealth on uptake of long-acting reversible contraception and access to medical abortion for women in rural and regional Australia using a stepped-wedge pragmatic cluster randomised controlled trial in general practice
Secondary ID [1] 306073 0
Medical Research Future Fund Primary Health Care Research Application APP1200453
Universal Trial Number (UTN)
U1111-1265-5843
Trial acronym
ORIENT (imprOving Rural and regIonal accEss to long acting reversible contraceptioN and medical abortion through nurse-led models of care, Tasksharing and telehealth)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Abortion 324720 0
Contraception 324905 0
Condition category
Condition code
Reproductive Health and Childbirth 322168 322168 0 0
Contraception
Reproductive Health and Childbirth 322169 322169 0 0
Abortion
Public Health 322170 322170 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We will undertake a five-year pragmatic cluster randomised controlled trial with a stepped-wedge approach to assess the effect of a complex intervention comprising delivery of a nurse-led model of care (involving task-sharing, and where appropriate implant insertion by nurses and use of telehealth) in general practice for improving women’s uptake of long-acting reversible contraception (LARC) and access to medical abortion (MA) in rural and regional Australia.
The delivery of this complex intervention will be supported by a set of implementation activities consisting of online education and clinical upskilling, educational outreach and participation in a digital community of practice (CoP). These activities will be made available to all participating practices; however, the start time will be staggered based on the intervention step to which the practices are randomly assigned to. Once practices enter the intervention phase, they will be invited to complete the clinical upskilling (activities 1-3) and educational outreach session (activity 4) within an eight-week period. Practices will be enrolled into the AusCAPPS CoP (activity 5) during this time. Engagement in the CoP will continue through to the end of the trial period.

Intervention support activities:
(1) Training in contraceptive implant insertion and removal: Practice nurses (PNs) and general practitioners (GPs) who have not previously undertaken implant training will participate in an online accredited implant insertion and removal training program. The training format will include an education (theory) component, the expected duration of which is 1.5 hours, and a separate simulation practice component of approximately 20 minutes. Participants will be encouraged to complete both components over four weeks.
The theory component will be delivered as an interactive, self-paced online course consisting of four modules. The first module will introduce contraceptive options, including implants and considerations for contraceptive initiation. The second module will include features of the contraceptive implant, clinical assessment, side effects, contraindications and patient information provision to facilitate and support informed decision-making. The third module will include Implanon procedures such as positioning of the patient, insertion information, local anaesthetic administration, and removal procedures. The fourth module will include contraception resources, and a summary slide-set of content covered in the theory component.
The simulation practice component will be delivered through a Zoom “virtual classroom”. In advance of this session, participants will receive a simulation equipment pack. During the session, participants will practice insertions and receive feedback from a credentialed clinical educator. The usual format is one trainer to one participant, or on occasion one trainer to two participants. This format provides a highly time efficient and individualised approach to simulation practice.
The course is RACGP accredited for 4 Category 2 points, and participants will receive a certificate upon completion.
(2) MS-2 Step prescriber training: GPs will complete the mandatory MS Health online medical abortion training to become certified prescribers of MS-2 Step, which is the composite pack containing the mifepristone-misoprostol combination regimen indicated for medical abortion. The layout of the training includes an introduction to the active ingredients in MS-2 Step (mifepristone and misoprostol), the mechanisms of action and history of use, and an overview of clinical literature. Participants are taken through the process of informed consent, patient eligibility, product administration, patient follow-up and aftercare, and management of complications. The training module also includes case studies to apply knowledge gained through participation in the module. Participants will be encouraged to complete the training over a four-week period.
(3) Online education on LARC and medical abortion: PNs will complete online modules on LARC and medical abortion, developed by the Centre for Excellence in Rural Sexual Health (CERSH). The module on medical abortion will take approximately three hours to complete and includes identifying the elements required for setting up a rural medical abortion service system, and clinical pathways for service provision within the practice. The module also covers the barriers and enablers to establishing and managing medical abortion service delivery.
The duration of the online module on LARCs is approximately three hours in length. The learning objectives include identifying patients best suited for LARCs, implementing a person-centred approach to patient education on how LARCs work, and the benefits and considerations of using LARC methods for contraception.
Both modules have a set of reinforcing activities as the final learning component to apply key concepts covered in each module. Participants will be encouraged to complete both modules over a four-week period. Each module attracts 6 Category 2 points for RACGP and 4 ACRRM professional development program (PDP) points.
(4) Academic detailing/educational outreach: Each participating practice will receive a single online educational outreach session lasting 60 minutes, modelled on the successful approach adopted by the National Prescribing Service (NPS) to encourage evidence-based practice. The hour-long session will be scheduled near the end of the eight-week intervention period once all clinical upskilling activities are completed. It will be co-facilitated by a NPS educational visitor, a GP opinion leader and a nurse opinion leader. The opinion leaders will be selected in advance based on their experience providing sexual and reproductive health services in primary care settings. NPS educational visitors will be responsible for running the session, including facilitating discussions amongst participants. The GP and nurse opinion leaders will offer peer-to-peer guidance on practical strategies for model implementation, drawing upon their experience providing sexual and reproductive healthcare services, specifically provision of implant and medical abortion services. This will include tailored advice to navigate and overcome logistical and clinical challenges that practices may anticipate in implementing the nurse-led model of care. At least two weeks prior to the delivery of each session, GP and nurse participants will each receive a pre-session pack containing: (1) a “detailing aid” with a customisable work plan to document how the model of care will be implemented in each practice, a summary billing options informational sheet and an infographic of the model of care for easy reference, and (2) a brief three-minute video introducing the nurse-led model of care and the steps involved for setting up and delivering LARC and medical abortion services using the model.
The delivery of the educational outreach sessions will be guided by a handbook specifically designed by the ORIENT research team to provide (a) background evidence underpinning the model, (b) an overview of the content to be covered in session, (c) the key messages that will be delivered, (d) the nurse-led model and considerations for implementation and (e) information on the AusCAPPS community of practice.

(5) Participation in an online Community of Practice: A national online Community of Practice (CoP) called the Australian Contraception and Abortion Primary Care Practitioner Support Network (hereafter referred to as AusCAPPS) has been developed under the guidance of partners from clinical professional groups and academia with interests in women’s sexual and reproductive health in primary care. AusCAPPS, hosted by Monash University, provides resources, training, and online clinical support for provision of LARC and medical abortion services. It contains interactive elements to inform, educate and support CoP members. These elements include:
• A discussion forum where members interact with each other by posting and/or responding to clinical questions, sharing practice tips, relevant news or research articles that spark discussion.
• Webinars and podcasts that take the form of instructional presentations, discussions and/or demonstrations that can be attended in real-time or viewed/listened to on-demand.
• Case studies of clinical issues in the context of realistic patient encounters to solicit member input on clinical decision-making that also considers social, financial, and environmental factors pertaining to the specific case relevant to the diagnostic and treatment process.
• A directory of members by state and the types of LARC and medical abortion services (e.g., MS-2Step prescriber or dispenser) that they provide, which will facilitate regional level peer networking and relationship-building across providers to support partnerships and referral pathways for improving delivery of LARC and medical abortion services
• A resource library that serves as a repository of relevant resources and information such as clinical guidelines, patient consent forms, treatment checklists and procedures, patient informational booklets etc., to support delivery of LARC and medical abortion services.
• Information on LARC and medical abortion training courses and modules for clinical upskilling
The ORIENT research implementation team will facilitate the logistics of participation across the various implementation support activities and monitor and encourage completion of each component. Verification of training completion for implant, MS-2Step and CERSH LARC and medical abortion training will occur by participants providing a copy of their certificates of completion and/or by the implementation team liaising directly with the training providers. Participation in the educational outreach session will be recorded by the NPS co-facilitator.

Intervention code [1] 322476 0
Other interventions
Comparator / control treatment
This trial uses a stepped-wedged design such that every cluster (practice) contributes data under both control and intervention observation periods. All 32 clusters will be randomised to one of four “steps”. The step that a practice is randomised to will determine the point in time that a practice switches from the control to the intervention phase. While all clusters eventually receive the intervention, data from clusters during the control phase (while practices are providing usual/standard care, i.e., care that is provided routinely in daily practice), will be compared with data from clusters during the intervention phase.
Control group
Active

Outcomes
Primary outcome [1] 329937 0
The primary outcome is the rate of LARC prescribing across participating practices. We will access data from Medicare on Pharmaceutical Benefits Scheme (PBS) dispensed prescriptions for the contraceptive implant (Implanon – PBS item no: 8487Q), and the two hormonal intra-uterine devices (Mirena – PBS item no: 8633J and Kyleena – PBS item no: 11909T). The number of consultations undertaken by the GP during each study phase will also be obtained from Medicare and used as denominators.
Timepoint [1] 329937 0
12 months pre- to 12 months post-delivery of the intervention
Secondary outcome [1] 404354 0
Rate of MS-2 Step prescribing (the combined pack of mifepristone/misoprostol prescribed for medical abortion) (PBS item no: 10211K) and the rate of telehealth services (multiple applicable MBS item numbers) provided by enrolled GPs in each cluster.
Timepoint [1] 404354 0
12 months pre- to 12 months post-delivery of the intervention
Secondary outcome [2] 404355 0
We will use the Realist Evaluation model involving quantitative and qualitative methods to understand “what worked for whom in what circumstances and why”. This evaluative framework examines context, mechanism, and outcomes and will consist of: (a) GPs and PNs completing a pre- and post-trial knowledge, attitudes, and practices (KAP) survey to identify changes that occurred and barriers and facilitators to the intervention and implementing the nurse-led model in practice (b) Semi-structured phone interviews with 20 GPs, 20 practice nurses and 20 practice managers to assess their perceptions of the research and intervention process, the impact on their practice, any new perspectives and concepts gained through participation and their identification of factors that can assist in scale up. Practice nurses will also be asked to consent 2 patients each (one consulted about contraception and one about medical abortion) during the intervention period for interviews about their experience of the model of care. (c) An examination of the quality of engagement with the CoP and patterns of use using digital analytics and qualitative assessments of discussion boards and related content posted on the CoP.
Timepoint [2] 404355 0
Process evaluation data will be collected throughout the trial: (a) The KAP surveys will be completed at baseline and 12 months after commencement of the intervention phase for practices in each step (b) The semi-structured phone interviews with GPs, practice nurses, practice managers and patients will be conducted 20 months after commencement of the intervention phase (c) Web analytics and CoP content data will be ongoing from the time of engagement commencement to the end of the trial period.
Secondary outcome [3] 404356 0
Health economic evaluation
A within-trial cost-effectiveness analysis from the Australian health provider perspective will be conducted to determine the relative costs and benefits of the nurse-led model of care on the prescribing rates of LARC and medical abortion compared to usual care.
Costs will be determined by estimating:
(a) the cost of the intervention (e.g., training, resources) and
(b) the direct costs of prescribing LARC or medical abortion (e.g., initial and subsequent consultation times, additional training, drug costs).
Data on resource use during the trial, including staff time for LARC and medical abortion provision, will be obtained where appropriate, via aggregated Medicare data and via surveys, costed at prevailing market rates.
Timepoint [3] 404356 0
Data for the health economic evaluation will be collected throughout the trial using: • Self-reported practice data, collected at baseline, six months and twelve months after the start of the intervention phase for each practice. • MBS and PBS data on LARC and medical abortion prescriptions, 12-months prior to and over the course of the trial period.
Secondary outcome [4] 404904 0
Rate of telehealth services (multiple applicable MBS item numbers) provided by enrolled GPs in each cluster.
Timepoint [4] 404904 0
12 months pre- to 12 months post-delivery of the intervention

Eligibility
Key inclusion criteria
Eligible practices must:
1. Be located in rural or regional Australia. We will use the Modified Monash Model to determine geographical eligibility of a practice. Areas classified to be in Modified Monash (MM) category 2 through to MM category 7 will be considered eligible for trial participation.
2. Have at least 2 GPs, a practice nurse and a practice manager enrol in the trial.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
General practices located in metropolitan areas (MM category 1), and practices that lack the minimum number of staff (GPs, practice nurse, practice manager) willing to enrol into the trial.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomisation will allocate clusters (general practices) to receive the intervention in four steps using a minimisation procedure to balance allocation of clusters with respect to geographic state, one or more GPs in the practice currently inserting intrauterine devices (IUDs) and location (regional/rural/remote). The regional, rural and remote classification will be determined using the Monash Modified Model classification system (MM2=regional centres, MM3=large rural towns, MM4=medium rural towns, MM5=small rural towns, MM6=remote, MM7=very remote).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Since this study uses a stepped-wedged design, all clusters will receive the intervention but in a staggered fashion. Data from clusters during the control phase (usual or standard care) will be compared with data from clusters during the intervention phase.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A sample size of 32 general practices (clusters) has 80% power to detect a 33% change in the primary outcome (p= 0.05, steps=4, practice dropout rate of 25%; intraclass correlation coefficient at 0.15). We assume that on average 2 GPs per practice will enrol. We estimate the rate of LARC prescribing to be 3 per 1000 GP surgery visits and expect a conservative increase of 33% in the rate of LARC prescribing based on the >50% increase observed in the ACCORd study.
Poisson regression models, with random effects for GP practice and fixed effects for time, stratification factors and intervention status, will be the main analyses for the primary and secondary outcomes of LARC and medical abortion prescribing rates respectively.
As the GP and PN level data are longitudinal samples, then a missing data analysis will be done on each longitudinal data set and investigations made for predictors of missingness. These investigations will examine the effect of key demographic and other factors particularly on the presence of missing outcomes. If outcome data is found to be not missing completely at random, then multiple imputation will be applied using the predictors for missingness.
For cost-effectiveness analyses, using well-established health economic principles, and accounting for clustering and time, the differences in costs will be compared to changes in the primary and secondary outcome measures (rates of LARC and medical abortion prescribing) between the nurse-led model of care and usual are. Sensitivity analyses will be conducted to explore the robustness and validity of the cost-effectiveness results and any uncertainty around mean costs and outcome measures.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/06/2022
Actual
23/06/2022
Date of last participant enrolment
Anticipated
23/12/2022
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
96
Accrual to date
36
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 310407 0
Government body
Name [1] 310407 0
Australian Government Department of Health
Country [1] 310407 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University, Department of General Practice, 1/270, Ferntree Gully Road, Notting Hill, vic 3168
Country
Australia
Secondary sponsor category [1] 311562 0
None
Name [1] 311562 0
Address [1] 311562 0
Country [1] 311562 0
Other collaborator category [1] 282092 0
University
Name [1] 282092 0
University of British Columbia
Address [1] 282092 0
Suite 930, 1125 Howe Street, Vancouver, BC Canada V6Z 2K8
Country [1] 282092 0
Canada
Other collaborator category [2] 282093 0
University
Name [2] 282093 0
Sydney University
Address [2] 282093 0
Johns Hopkins Dr, Camperdown NSW 2050
Country [2] 282093 0
Australia
Other collaborator category [3] 282094 0
University
Name [3] 282094 0
La Trobe University
Address [3] 282094 0
Level 3, George Singer Building, Bundoora, VIC, 3086
Country [3] 282094 0
Australia
Other collaborator category [4] 282095 0
University
Name [4] 282095 0
Centre for Excellence in Rural Sexual Health (CERSH), University of Melbourne
Address [4] 282095 0
696, University of Melbourne, Shepparton Campus, 49 Graham St, Shepparton VIC 3630
Country [4] 282095 0
Australia
Other collaborator category [5] 282096 0
University
Name [5] 282096 0
Centre for Health Economic Research and Evaluation University technology Sydney
Address [5] 282096 0
CHERE, University of Technology Sydney
PO Box 123 Broadway NSW 2007
Country [5] 282096 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310055 0
Monash University Human Research Ethics Committee.
Ethics committee address [1] 310055 0
Monash Graduate Research Office, 26 Sports Walk, Clayton VIC 3168
Ethics committee country [1] 310055 0
Australia
Date submitted for ethics approval [1] 310055 0
01/10/2021
Approval date [1] 310055 0
23/11/2021
Ethics approval number [1] 310055 0
29476

Summary
Brief summary
Accessing effective contraception and abortion services for women living in rural and regional areas can be challenging. The study’s primary aim is to assess the effectiveness of a nurse-led model of care (involving task-sharing, and where appropriate implant insertion by nurses and use of telehealth) in general practice for improving women’s uptake of long-acting reversible contraception and access to medical abortion in rural and regional areas. We will utilise a stepped-wedge, cluster randomised controlled trial study design to trial this complex intervention in regional and rural general practices in Australia. The delivery of the nurse-led model will be supported by a set of implementation activities consisting of (a) online education and clinical upskilling for LARC and medical abortion care, (b) educational outreach to discuss practical strategies for model implementation, and (c) participation in a digital community of practice for access to clinical experts, peer support and resources to support provision of LARC and medical abortion services. It is anticipated that broadening the scope of practice nurses to provide LARC and EMA services in general practice and supporting them in providing this service will be effective in helping overcome issues of access to LARC and medical abortion services for women living in regional and rural Australia. This has the potential to improve reproductive health outcomes for this priority population in Australia.
Trial website
https://www.spherecre.org/the-orient-study
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 116330 0
Prof Danielle Mazza
Address 116330 0
Department of General Practice, Monash University, 1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 116330 0
Australia
Phone 116330 0
+61 3 9902 4512
Fax 116330 0
Email 116330 0
danielle.mazza@monash.edu
Contact person for public queries
Name 116331 0
Prof Danielle Mazza
Address 116331 0
Department of General Practice, Monash University, 1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 116331 0
Australia
Phone 116331 0
+61 3 9902 4512
Fax 116331 0
Email 116331 0
danielle.mazza@monash.edu
Contact person for scientific queries
Name 116332 0
Prof Danielle Mazza
Address 116332 0
Department of General Practice, Monash University, 1/270 Ferntree Gully Rd, Notting Hill VIC 3168
Country 116332 0
Australia
Phone 116332 0
+61 3 9902 4512
Fax 116332 0
Email 116332 0
danielle.mazza@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the sensitive nature of the research, individual participant data will not be publicly available


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14467Ethical approval    383318-(Uploaded-17-12-2021-10-07-22)-Study-related document.pdf



Results publications and other study-related documents

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